The digital health space refers to the integration of technology and health care services to improve the overall quality of health care delivery. It encompasses a wide range of innovative and emerging technologies such as wearables, telehealth, artificial intelligence, mobile health, and electronic health records (EHRs). The digital health space offers numerous benefits such as improved patient outcomes, increased access to health care, reduced costs, and improved communication and collaboration between patients and health care providers. For example, patients can now monitor their vital signs such as blood pressure and glucose levels from home using wearable devices and share the data with their doctors in real-time. Telehealth technology allows patients to consult with their health care providers remotely without having to travel to the hospital, making health care more accessible, particularly in remote or rural areas. Artificial intelligence can be used to analyze vast amounts of patient data to identify patterns, predict outcomes, and provide personalized treatment recommendations. Overall, the digital health space is rapidly evolving, and the integration of technology in health

Tuesday, April 28, 2015

The Jagged Path to Electronic Health Record Interoperability

The early vision of EHR interoperability was formulated by the first ONC head, David Brailer M.D. in 2006. It was part of a greater study on Information Technology by George W. Bush when he created ONC with an executive order.

Since that time we have had a series of ONC chiefs, each one with a different emphasis and focus on the growth of infrastructure to support health data exchanges.

Interoperatiliby is actually a misnomer, because EHRs, regardless of harmonization do not communicate with each other directly, and only contain certain data sets that can be decoded by intervening software.  There are some networked EHRs that provide true communication among multiple site using their own proprietary software. However, these are actually closed silos unless conntected to a regional health data exchange.

The extent and cost of a HDE is a function of the number of fields to be linked. The most common set is the CCR and it is also the basic standard.

Connecting two or more disparate systems is a technical challenge, however the legalese and bureaucracy are also challenged by state regulations.  Trust agreements are a necessity to ensure security and privacy as well. Networks that cross state lines present a special set of challenges.

Economic stability for the HDE is a critical ingredient, and that may vary greatly according to region. The most challenging cases are those connecting multiple small institutions, small hospitals and medical groups.  Large institutions and metropolitan areas have the financial strength to invest in HDEs.

In order to qualify for certain Federal incentives the HDE must contain functions such as secure portals, messaging, all in accord with HIPAA regulation.

Fast forward to 2015

ONC's Karen DeSalvo outlines 3 steps to interoperability

National Coordinator for Health IT Karen DeSalvo continues to tout "the bright future" of health IT, outlining in a post atHealth Affairs what needs to be done to get to full interoperability.

Her steps to getting to interoperability include:
  1. Standardizing application programming interfaces and implementation standards.
  2. Creating clarity around the environment of trust. "What are the shared expectations and actions around data security and privacy?" she asks.
  3. Providing incentives for interoperability and the appropriate uses of electronic health information.
However, she also writes about the problems states still face when it comes to adoption. In Alabama, for example, providers face a lack of broadband access in undeserved communities. In New Jersey differing privacy laws in neighboring states are a barrier to information exchange, she writes.

 We will need an unprecedented amount of cooperation, collaboration, and transparency to see that there is the best public private partnership possible .…

Her undaunted cry is:

 "We will need an unprecedented amount of cooperation, collaboration, and transparency to see that there is the best public private partnership possible" .…creates the challenge to all vendors, state and federal entities and cooperation at the local  to achieve.

Electronic Informed Consent: New Guidance-Implications and Implementation


The transition to EHR involves far more that medical records. Paper based documents and processes such as Informed Consent has also entered the digital age.  Along with that change comes other regulatory requirement for Clinical Trials, IRBs.  These include changes which include requirements for the  FDA.


Course Description:

For those who manage clinical trials, collecting informed consent through traditional paper-based methods is quickly becoming outdated.  Electronic media offers many advantages for both patients and the advancement of scientific research. 
FDA recently released a draft information sheet on electronic informed consent (eICFs) that has significant implications for industry. Following this, the Office for Human Research Protections (OHRP) has released a request for comment which asks researchers whether the guidance should be applicable to both FDA and OHRP regulated trials. 
Understanding what these updates mean for your current procedures will allow your team to adjust operations according to the changing landscape. This course  will address the implementation logistics of the questions answered by the FDA in the guidance, to allow you to develop an implementation plan for the short and long term. Come to this session to learn how to take the FDA recommendations into specific industry settings including sites, sponsors and IRBs.  

REGISTER >>>>>Electronic Informed Consent: New Guidance-Implications and Implementation

The next landscape change will occur to reduce duplications, errors and increase the uniformity of informed consent for routine medical procedures including electronic signature verification via secured certification keys. Much like 'Verisign, 


Saturday, April 25, 2015

Symantec Government Symposium


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Last year, data breaches of both private sector companies and the federal government dominated headlines. In short, a lot of organizations got owned. And if early 2015 is any indication, there’s much more to come.

THESE 3 STEPS COULD PREVENT 85 PERCENT OF ALL DATA BREACHES


Last year, data breaches of both private sector companies and the federal government dominated headlines.
In short, a lot of organizations got owned. And if early 2015 is any indication, there’s much more to come.
Yet, a great many of these calamities are preventable through basic cybersecurity hygiene, according to Ann Barron-DiCamillo, one of the U.S. government’s foremost cybersecurity experts.
DiCamillo, the director of the Department of Homeland Security’s Computer Emergency Readiness Team, told an audience at the Symantec Government Symposium on Wednesday that about 85 percent of data breach incidents could be prevented by following three essential steps:
  • Reducing administrative privileges (think Edward Snowden’s access to National Security Agenda data);
  • Application whitelisting (Not letting unauthorized programs run because, well, why would you?); and
  • Software application patching (This has been a problem for more than a decade).


“These controls, if monitored, would reduce about 85 percent of incidents,” DiCamillo said. “We’re trying to emphasize the importance of getting back to cyber hygiene.”

Healthcare was largely immune to cyberintrusions prior to HITECH, EHR, the Affordable Care Act and Health Data Exchanges. Health care ran largely on paper and pen. Today it is a far different story.

Other News

GAO To Release HealthCare.gov Cybersecurity Report in 2015

Patients, Doctors See Mobile Health App Benefits, but Privacy Concerns Remain--podcast

Deborah Estrin, a professor of computer science at Cornell Tech, Evan Muse, a cardiologist and fellow at Scripps Translational Science Institute, Deborah Peel, a psychiatrist and founder of Patient Privacy Rights, and Whitney Zatzkin, a user of mobile health applications, spoke with iHealthBeat about the growing use of mobile health apps. (podcast)

Upcoming Events:

Big Data in Healthcare Summit 2015 | April 28-30, Boston
iHT2 Health IT Summit | May 19-20, Boston